Anastomosis formation with magnetic devices having temporary retention member

ABSTRACT

Systems and methods for forming an anastomosis between two adjacent walls of a digestive tract are provided. The system can include a first and second magnetic implants that are configured to magnetically couple to each other through the two adjacent walls of the digestive tract to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period. The system can also include a retention member that can extend outwardly from a corresponding one of the first and second magnetic implants, the retention member being configured to retain the first and second magnetic implants in position and prevent passage thereof through the necrotic area during the healing time period.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority from U.S. provisional patentapplication No. 63/080,363, filed on Sep. 18, 2020, and entitled“ANASTOMOSIS FORMATION WITH MAGNETIC DEVICES HAVING TEMPORARY RETENTIONMEMBER”, the disclosure of which is hereby incorporated by reference inits entirety.

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ELECTRONICALLY

Incorporated by reference in its entirety herein is a computer-readablenucleotide/amino acid sequence listing submitted concurrently herewithand identified as follows: One 15,000 Byte ASCII (Text) file named“2021-11-10_Sequence_Listing_ST25” created on Nov. 10, 2021.

TECHNICAL FIELD

The technical field generally relates to medical techniques for treatingdigestive tract conditions. In particular, the technical field relatesto medical techniques including devices for forming an anastomosis inthe digestive tract.

BACKGROUND

Metabolic surgeries and medical procedures to treat conditionsassociated with the digestive tract, diabetes and obesity often requirealteration of the digestive tract through incisions, sutures, puncturesand/or stapling, which can cause trauma to the organ being altered andlead to bleeding. For instance, bariatric surgery procedures can be usedto treat obesity, and can be aimed at bypassing a portion of the stomachand/or the intestine. Such medical procedures can also lead to anincreased risk of infection or other complications.

Magnetic compression anastomosis can be used in the context of medicalprocedures to treat conditions associated with the digestive tract. Withmagnetic compression anastomosis, necrosis is induced in tissuesandwiched between two magnets. A healing process takes place around themagnets, while the compressed tissue eventually dies and separates fromsurrounding living tissue. The magnets are released along with thenecrotic tissue, leaving an open passage known as an anastomosis.

There remain a number of challenges with respect to surgery proceduresin the digestive tract, particularly in the formation of an anastomosis.

SUMMARY

In accordance with an aspect, there is provided a system for forming ananastomosis between two adjacent walls of a digestive tract, the systemcomprising:

-   -   first and second magnetic implants configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period; and    -   a retention member extending outwardly from a corresponding one        of the first and second magnetic implants, the retention member        being configured to retain the first and second magnetic        implants in position and prevent passage thereof through the        necrotic area during the healing time period.

In some implementations, at least one of the first and second magneticimplants comprises a housing configured to house a magnet therein.

In some implementations, the housing of the at least one of the firstand second magnetic implants fully encloses the magnet therein.

In some implementations, at least one of the first and second magneticimplants comprises multiple magnets.

In some implementations, the multiple magnets are connected to eachother by a cable, a string, a ribbon, a hitch, or a combination thereof.

In some implementations, the multiple magnets are housed within a singlehousing.

In some implementations, the single housing comprises a lumen-orientedportion and a tissue-contacting portion.

In some implementations, at least one of the first and second magneticimplants comprises a flat compression surface.

In some implementations, each one of the multiple magnets is housedwithin a corresponding housing.

In some implementations, the multiple magnets are interconnected to forma geometrically-shaped array once implanted in the digestive tract.

In some implementations, the geometrically-shaped array is a lineararray, a circular array, or an octagonal array.

In some implementations, each of the corresponding housings comprises aflat compression surface.

In some implementations, at least one of the first and second magneticimplants comprises a connecting member connectable to a connectorextending from a corresponding endoscope to be releasably engageablewith the connector.

In some implementations, the connector is a delivery catheter.

In some implementations, the connecting member comprises a deliverycatheter attachment assembly connectable to the delivery catheter.

In some implementations, the connecting member comprises a pommel snareor a knob.

In some implementations, the retention member comprises a flange or aseries of flanges.

In some implementations, the retention member comprises a flange or aseries of flanges that is integral with the housing.

In some implementations, the retention member comprises a flange or aseries of flanges that is discrete from the housing.

In some implementations, the retention member comprises a continuous rimextending circumferentially around a corresponding one of the first andsecond magnetic implants.

In some implementations, the retention member comprises discrete arms.

In some implementations, the retention member and the housing are madeof a same material.

In some implementations, the retention member and the housing are madeof a different material.

In some implementations, the retention member and the housing aremanufactured in a same manufacturing process.

In some implementations, the retention member and the housing aremanufactured in a different manufacturing process.

In some implementations, the retention member is attachable, engageable,or couplable to the housing following the different manufacturingprocess.

In some implementations, the retention member comprises at least one ofa bioerodible material, a biodegradable material, and a bioresorbablematerial.

In some implementations, the retention member comprises a syntheticaliphatic polyester.

In some implementations, the retention member comprises at least one ofpolylactic acid, polyglycolic acid, polylactic-co-glycolic acid,polycaprolactone, and polydioxanone.

In some implementations, the bioerodible material is a bioerodiblehydrogel.

In some implementations, the retention member comprises at least twomaterials, the at least two materials having a different dissolutionrate or a different degradation rate once implanted in a givenenvironment.

In some implementations, the retention member comprises at least onenotch or spot having a dissolution rate or a degradation rate that isdifferent from a remainder thereof once implanted in a givenenvironment.

In some implementations, the retention member of the first and secondmagnetic implants is made of a same material.

In some implementations, the retention member of the first magneticimplant is made from a different material than the retention member ofthe second magnetic implant.

In some implementations, the first magnetic implant is configured forimplantation in a strongly acidic environment and the second magneticimplant is configured for implantation in a weakly acidic environment,and once implanted in the strong acidic environment and in the weakacidic environment respectively, the first and second retention memberhave a similar dissolution rate or degradation rate.

In some implementations, the retention member comprisespolydimethylsiloxane or a fluoropolymer.

In some implementations, the retention member comprises a titaniumalloy, cobalt chromium, or an austenitic stainless steel.

In some implementations, the retention member comprises an elastomericmaterial.

In some implementations, the retention member of the first magneticimplant and the retention member of the second magnetic implant have asame configuration.

In some implementations, the retention member of the first magneticimplant and the retention member of the second magnetic implant have adifferent configuration.

In some implementations, the retention member comprises anoutwardly-extending inner surface oriented towards the tissue of thedigestive tract, the outwardly-extending inner surface beingsubstantially flat.

In some implementations, the retention member comprises anoutwardly-extending inner surface oriented towards the tissue of thedigestive tract, the outwardly-extending inner surface comprising acurvature.

In some implementations, the outwardly-extending inner surface has alength between about 0.5 mm and about 10 mm.

In some implementations, a gap is defined between theoutwardly-extending inner surfaces of the retention members of thecorresponding first and second magnetic implants once implanted in thedigestive tract.

In some implementations, wherein the gap is at least 0.2 mm.

In some implementations, the retention member comprises anoutwardly-extending outer surface that is continuous with a top surfaceof a corresponding one of the first and second magnetic implants.

In some implementations, the retention member comprises anoutwardly-extending outer surface, and wherein a transition from theoutwardly-extending surface to a top surface of a corresponding one ofthe first and second magnetic implants defines a step change.

In some implementations, the retention member is rigid.

In some implementations, the retention member is flexible.

In some implementations, the retention member is defeatable followingthe healing time period.

In some implementations, the retention member is defeatable mechanicallyusing an endoscope.

In some implementations, the retention member is defeatable via adissolution mechanism or a degradation mechanism.

In some implementations, the retention member extends outwardly from thecorresponding one of the first and second magnetic implants at a rightangle.

In some implementations, the retention member extends outwardly from thecorresponding one of the first and second magnetic implants at an obtuseangle.

In some implementations, the retention member extends outwardly from thecorresponding one of the first and second magnetic implants at an acuteangle.

In some implementations, the retention member comprises a portion thatis foldable against the corresponding one of the first and secondmagnetic implants for delivery within the digestive tract, the foldableportion being configured to unfurl once the corresponding one of thefirst and second magnetic implants is implanted within the digestivetract.

In some implementations, the retention member is configured to adopt aretracted configuration for delivery within the digestive tract, and anexpanded configuration once a corresponding one of the first and secondmagnetic implants is implanted within the digestive tract.

In some implementations, the retention member comprises aself-expandable material.

In some implementations, the retention member comprises a shape-memorymaterial

In some implementations, the retention member changes from the retractedconfiguration to an expended configuration following a change intemperature.

In some implementations, the shape-memory material comprises nitinol.

In some implementations, the retention member comprises a biasingmechanism.

In some implementations, the retention member comprises a layer of adrug promoting fibrosis or tissue repair.

In some implementations, the retention member comprises a lubriciouscoating.

In some implementations, the retention members of the first and secondmagnetic implants are configured such that the implant remain within thedigestive tract for at least about 2 weeks or for about 2 weeks to about4 weeks.

In some implementations, the retention member is configured such thatthe first and second magnetic implants are passed via manipulation of anexternal magnet or by an endoscopic device.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second magnetic implants configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period; and    -   a retention member extending outwardly from at least one of the        first and second magnetic implants, the retention member being        configured to retain the first and second magnetic implants in        position and prevent passage thereof through the necrotic area        during the healing time period.

In some implementations, the system further comprises one or morefeatures as defined herein and/or described herein and/or illustratedherein.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second magnetic implants each comprising a        tissue-contacting portion and being configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period, the        tissue-contacting portion of the first magnetic implants        comprising:    -   a standoff feature being configured to maintain a space between        respective tissue-contacting portions of the first and second        magnetic implants when the standoff feature contacts the        tissue-contacting portion of the second magnetic implant;    -   a retention member extending outwardly from a corresponding one        of the first and second magnetic implants, the retention member        being configured to retain the first and second magnetic        implants in position and prevent passage thereof through the        necrotic area during the healing time period.

In some implementations, the standoff feature includes a plurality ofstandoff features provided in a spaced-apart relationship.

In some implementations, the tissue-contacting portion of the secondmagnetic implant is substantially flat.

In some implementations, the tissue-contacting portion of the secondmagnetic implant comprises a recess having a shape that is complimentaryto the standoff feature, the standoff feature having a higher heightthan a depth of the recess.

In some implementations, the standoff feature has a circular shape.

In some implementations, the standoff feature has a polygonal shape.

In some implementations, the standoff feature comprises angled sideswalls.

In some implementations, the standoff feature comprises sides wallsprovided at a substantially right angle.

In some implementations, the standoff feature is configured to provide afocal pressure gradient therearound.

In some implementations, the system further comprises one or morefeatures as defined herein and/or described herein and/or illustratedherein.

In accordance with another aspect, there is provided a device forforming an anastomosis between two adjacent walls of a digestive tract,the device comprising:

-   -   a first and second magnets configured to magnetically couple to        each other through the two adjacent walls of the digestive tract        to compress a portion of the two adjacent walls therebetween and        form a necrotic area that becomes surrounded by a scarred edge        following a healing time period; and    -   a flange for retaining the pair of magnets once coupled within        the digestive tract during the healing time period, the flange        being couplable to a corresponding one of the first and second        magnetic implants.

In some implementations, the device further comprises one or morefeatures as defined herein and/or described herein and/or illustratedherein.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second magnetic implants configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period, at least one of        the first and second magnetic implants comprising:        -   a magnet; and        -   a housing configured to house the magnet therein; and    -   a retention member extending outwardly from a corresponding one        of the first and second magnetic implants, the retention member        being configured to retain the first and second magnetic        implants in position and prevent passage thereof through the        necrotic area during the healing time period;    -   wherein at least one of the housing and the retention member is        configured to enable release of a drug therefrom once implanted        in the digestive tract.

In some implementations, the retention member and the housing are madeof a same material.

In some implementations, the retention member and the housing are madeof a different material.

In some implementations, the material from which is made the at leastone of the housing and the retention member comprises a matrix that isconfigured to include the drug therein up to a given timepoint onceimplanted in the digestive tract.

In some implementations, the matrix is configured to progressivelyrelease the drug therefrom once the at least one of the housing and theretention member is implanted in the digestive tract.

In some implementations, the matrix comprises a bioerodible materialthat is configured to undergo degradation once implanted in thedigestive tract.

In some implementations, the bioerodible material comprises at least oneof polylactic acid, polyglycolic acid and polylactic-co-glycolic acid.

In some implementations, the bioerodible material comprisespolydimethylsiloxane.

In some implementations, the drug has at least one of pro-thrombosisproperties, antifibrinolytic properties and wound-healing properties.

In some implementations, the drug comprises at least one of tranexamicacid, aprotinin, epsilon-aminocaproic acid, aminomethylbenzoic acid,aminocaproic acid, insulin, matrikines, and antibiotics.

In some implementations, the drug comprises a peptide.

In some implementations, the drug comprises a plurality of drugs.

In some implementations, the matrix is configured such that at least twodrugs of the plurality of drugs are released therefrom sequentially.

In some implementations, the plurality of drugs comprises anantifibrinolytic drug and a wound-healing promoting drug, and theantifibrinolytic drug is released first and the wound-healing promotingdrug is released second.

In some implementations, the matrix is configured such that at least twodrugs of the plurality of drugs are released therefrom substantiallysimultaneously.

In some implementations, the system further comprises one or morefeatures as defined herein and/or described herein and/or illustratedherein.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second magnetic implants configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period, at least one of        the first and second magnetic implants comprising:        -   a magnet; and        -   a housing configured to house the magnet therein; and    -   a retention member extending outwardly from a corresponding one        of the first and second magnetic implants, the retention member        being configured to retain the first and second magnetic        implants in position and prevent passage thereof through the        necrotic area during the healing time period.    -   wherein at least one of the housing and the retention member is        configured to contain a biologically active component therein.

In some implementations, the biologically active component comprisesviable cells.

In some implementations, the biologically active component comprises atleast one of fibroblast and stem cells.

In some implementations, the at least one of the housing and theretention member is configured to progressively release the biologicallyactive component therefrom once implanted in the digestive tract.

In some implementations, the at least one of the housing and theretention member comprises a bioresorbable material.

In some implementations, the at least one of the housing and theretention member comprises a semi-permeable membrane.

In some implementations, the semi-permeable membrane is configured toenable diffusion of oxygen and cell nutrients.

In some implementations, the biologically active component comprises aplurality of biologically active components.

In some implementations, the wherein the at least one of the housing andthe retention member is configured such that at least two biologicallyactive components of the plurality of drugs are released therefromsequentially.

In some implementations, the wherein the at least one of the housing andthe retention member is configured such that at least two drugs of theplurality of biologically active components are released therefromsubstantially simultaneously.

In some implementations, the system further comprises one or morefeatures as defined herein and/or described herein and/or illustratedherein.

In accordance with another aspect, there is provided a method forforming an anastomosis between two adjacent walls of a digestive tractof a patient, the method comprising:

-   -   navigating a first magnetic implant into the digestive tract to        a first location on one side of a desired anastomose site;    -   delivering a second magnetic implant into the digestive tract to        a second location on another side of the desired anastomose        site;    -   magnetically coupling the first and second magnetic implants to        each other through the two adjacent vessel walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area; and    -   retaining the first and second magnetic implants in position on        respective sides of the two adjacent walls during a healing time        period to enable formation of a scarred edge that surrounds the        necrotic area.

In some implementations, navigating the first magnetic implant comprisesreleasably engaging the first and second magnetic implants with acorresponding delivery catheter insertable in a working channel of acorresponding endoscope via a connecting member.

In some implementations, the method further comprises mechanicallydefeating the retention member using an endoscope following the healingtime period.

In some implementations, the method further comprises passing at leastone of the first and second magnetic implants via the bowel lumen bymanipulating a magnet externally or by manipulating an endoscopic deviceinternally.

In some implementations, retaining the first and second magneticimplants in position on respective sides of the two adjacent wallscomprises providing a retention member extending outwardly from each oneof the first and second magnetic implants to prevent passage thereofthrough the necrotic area.

In accordance with another aspect, there is provided a method forforming an anastomosis between two adjacent walls of a digestive tractof a patient, the method comprising:

-   -   magnetically coupling a first and second magnetic implants to        each other through the two adjacent vessel walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area, each one of the first and        second magnetic implants comprising a flange extending outwardly        therefrom;    -   holding the first and second magnetic implants in position on        respective sides of the two adjacent walls during a healing time        period to enable formation of a scarred edge that surrounds the        necrotic area during which the flange of each one of the first        and second magnetic implants prevents passage thereof through        the necrotic area.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second elongated magnetic implants configured to        magnetically couple to each other through the two adjacent walls        of the digestive tract to compress a portion of the two adjacent        walls therebetween and form a necrotic area that becomes        surrounded by a scarred edge following a healing time period;        and    -   a retention member extending outwardly from at least one of the        first and second elongated magnetic implants, the retention        member being configured to retain the first and second elongated        magnetic implants in position and prevent passage thereof        through the necrotic area during the healing time period.

In some implementations, the at least one of the first and secondelongated magnetic implants comprises a housing configured to house amagnet therein.

In some implementations, the retention member comprises a flange or aseries of flanges.

In some implementations, the flange extends continuously aroundsubstantially an entire periphery of the at least one of the first andsecond elongated magnetic implants.

In some implementations, the retention member comprises a flange or aseries of flanges that is integral with the housing.

In some implementations, the retention member comprises a flange or aseries of flanges that is discrete from the housing.

In some implementations, the retention member comprises a series offlanges extending around a periphery of the at least one of the firstand second elongated magnetic implants, the flanges being provided in aspaced-apart relationship relative to one another.

In some implementations, the retention member comprises a continuous rimextending circumferentially around the at least one of the first andsecond elongated magnetic implants.

In some implementations, the retention member has a T-shapedcross-section.

In some implementations, the retention member and the housing are madeof a same material.

In some implementations, the retention member and the housing are madeof a different material.

In some implementations, the retention member comprises at least one ofa bioerodible material, a biodegradable material, and a bioresorbablematerial.

In some implementations, the retention member comprises at least twomaterials, the at least two materials having a different dissolutionrate or a different degradation rate once implanted in a givenenvironment.

In some implementations, the retention member comprises at least onenotch or spot having a dissolution rate or a degradation rate that isdifferent from a remainder thereof once implanted in a givenenvironment.

In some implementations, each one of the first and second elongatedmagnetic implants comprises a corresponding retention member extendingoutwardly therefrom, the corresponding retention member of the first andsecond elongated magnetic implants being made of a same material.

In some implementations, each one of the first and second elongatedmagnetic implants comprises a corresponding retention member extendingoutwardly therefrom, the corresponding retention member of the firstmagnetic implant being made from a different material than thecorresponding retention member of the second magnetic implant.

In some implementations, the first elongated magnetic implant isconfigured for implantation in a strongly acidic environment and thesecond elongated magnetic implant is configured for implantation in aweakly acidic environment, and once implanted in the strongly acidicenvironment and in the weak acidic environment respectively, the firstand second elongated retention member have a similar dissolution rate ordegradation rate.

In some implementations, the retention member comprises anoutwardly-extending inner surface oriented towards the tissue of thedigestive tract, the outwardly-extending inner surface beingsubstantially flat.

In some implementations, the retention member comprises anoutwardly-extending inner surface oriented towards the tissue of thedigestive tract, the outwardly-extending inner surface comprising acurvature.

In some implementations, each one of the first and second elongatedmagnetic implants comprises a corresponding retention member extendingoutwardly therefrom, each one of the corresponding retention memberscomprising an outwardly-extending inner surface oriented towards thetissue of the digestive tract, a gap being defined between theoutwardly-extending inner surfaces of the corresponding retentionmembers of the first and second elongated magnetic implants onceimplanted in the digestive tract.

In some implementations, the retention member comprises a portion thatis foldable against the at least one of the first and second elongatedmagnetic implants for delivery within the digestive tract, the foldableportion being configured to unfurl once the at least one of the firstand second elongated magnetic implants is implanted within the digestivetract.

In some implementations, the retention member is configured to adopt aretracted configuration for delivery within the digestive tract, and anexpanded configuration once the at least one of the first and secondelongated magnetic implants is implanted within the digestive tract.

In accordance with another aspect, there is provided a system forforming an anastomosis between two adjacent walls of a digestive tract,the system comprising:

-   -   first and second elongated magnetic implants each comprising a        tissue-contacting portion and being configured to magnetically        couple to each other through the two adjacent walls of the        digestive tract to compress a portion of the two adjacent walls        therebetween and form a necrotic area that becomes surrounded by        a scarred edge following a healing time period, the        tissue-contacting portion of the first elongated magnetic        implant comprising:        -   a standoff feature being configured to maintain a space            between respective tissue-contacting portions of the first            and second elongated magnetic implants when the standoff            feature contacts the tissue-contacting portion of the second            elongated magnetic implant;    -   a retention member extending outwardly from at least one of the        first and second elongated magnetic implants, the retention        member being configured to retain the first and second elongated        magnetic implants in position and prevent passage thereof        through the necrotic area during the healing time period.

In some implementations, the standoff feature includes a plurality ofstandoff features provided in a spaced-apart relationship.

In some implementations, the tissue-contacting portion of the secondelongated magnetic implant is substantially flat.

In some implementations, the tissue-contacting portion of the secondelongated magnetic implant comprises a recess having a shape that iscomplimentary to the standoff feature, the standoff feature having ahigher height than a depth of the recess.

In some implementations, the standoff feature comprises angled sideswalls.

In some implementations, the standoff feature comprises sides wallsprovided at a substantially right angle.

In some implementations, the standoff feature is configured to provide afocal pressure gradient therearound.

BRIEF DESCRIPTION OF THE DRAWINGS

The attached figures illustrate various features, aspects andimplementations of the technology described herein.

FIG. 1 is an exploded perspective view of a first magnetic implant shownon one side of a desired site of an anastomosis and of a second magneticimplant shown on another side of the desired site of the anastomosis,with a vessel wall of a first hollow organ and a vessel wall of a secondhollow organ being shown therebetween, in accordance with animplementation.

FIG. 2 is a perspective view of the first and second magnetic implantsshown in FIG. 1 , with the first magnetic implant being shown in contactwith the vessel wall of the first hollow organ and the second magneticimplant being shown in contact with the vessel wall of the second holloworgan, at the desired site of the anastomosis.

FIG. 3 is a side view of the first and second magnetic implants shown inFIG. 2 .

FIG. 4A is a perspective view of a magnetic implant and of a retentionmember, in accordance with an implementation.

FIG. 4B is a side view of the magnetic implant of FIG. 4A.

FIG. 5 is an exploded view of the magnetic implant of FIG. 4A.

FIG. 6 is a cross-sectional view of the magnetic implant of FIG. 4A.

FIG. 7 is a cross-sectional view of a first magnetic implant shown onone side of a desired site of an anastomosis and of a second magneticimplant shown on another side of the desired site of the anastomosis,with a vessel wall of a first hollow organ and a vessel wall of a secondhollow organ being shown therebetween, the first magnetic implantincluding a compression surface that is inwardly curved and the secondmagnetic implant including a compression surface that is outwardlycurved.

FIG. 8 is a perspective view of first and second magnetic implantshaving an annular shape, in accordance with an implementation.

FIGS. 9A-9C are side views of a magnetic implant that includes multiplemagnets provided in series and in an adjacent relationship and connectedby a cable that is manipulated to yield an annular shape.

FIGS. 10A-10D are side views of a magnetic implant that includesmultiple magnets, the magnetic implant unfolding to form a polygonalshape without a void space.

FIGS. 11A-11D are side views of a magnetic implant that includesmultiple magnets provided in a first configuration wherein two layers ofmagnets are in a side-by-side relationship, and in a secondconfiguration wherein the two layers of magnets are spaced-apart.

FIG. 12 is a side view of first and second magnetic implants andcorresponding retention members, with the first magnetic implant beingshown in contact with a vessel wall of a first hollow organ and thesecond magnetic implant being shown in contact with a vessel wall of asecond hollow organ, at the desired site of the anastomosis, inaccordance with another implementation.

FIG. 13 is a side view of first and second magnetic implants andcorresponding retention members, with the first magnetic implant beingshown in contact with a vessel wall of a first hollow organ and thesecond magnetic implant being shown in contact with a vessel wall of asecond hollow organ, at the desired site of the anastomosis, inaccordance with another implementation.

FIG. 14 is a side view of a magnetic implant and of a retention memberprovided at an angle relative to a compression surface of the magneticimplant, in accordance with another implementation.

FIG. 15 is a side view of a magnetic implant and of a retention memberprovided at an angle relative to a compression surface of the magneticimplant, in accordance with another implementation.

FIG. 16 is a top view of a magnetic implant that includes a series offlanges, with a first flange at 12 o'clock, a second flange at 3o'clock, a third flange at 6 o'clock, and a fourth flange at 9 o'clock,in accordance with another implementation.

FIG. 17 is a top view of a magnetic implant that includes a series offlanges provided in a spaced-apart relationship around a periphery ofthe magnetic implant, in accordance with another implementation.

FIG. 18 is a side view of a magnetic implant and of a retention memberthat includes thinner portions, in accordance with anotherimplementation.

FIG. 19 is a side view of a magnetic implant and of a retention memberhaving an outwardly-extending inner surface that contacts an outersurface of a vessel of a hollow organ, in accordance with anotherimplementation.

FIG. 20 is a perspective view of a portion of an endoscope, of adelivery catheter loaded into a working channel of the endoscope andthat includes a snare, and of a magnetic implant, the magnetic implantincluding a pommel snare to enable the magnetic implant to be releasablyattachable to a distal end of the delivery catheter using the snare, inaccordance with an implementation.

FIG. 21 is a perspective view of a portion of an endoscope, of adelivery catheter loaded into a working channel of the endoscope andthat includes a snare, and of a magnetic implant, the magnetic implantincluding a pommel snare to enable the magnetic implant to be releasablyattachable to a distal end of the delivery catheter using the snare, inaccordance with another implementation.

FIG. 22 is a perspective view of a portion of an endoscope, of adelivery catheter loaded into a working channel of the endoscope andthat includes a grabber having a U-shaped jaw, and of a magnetic implantthat includes a loop to enable the magnetic implant to be releasablyattachable to a distal end of the delivery catheter using the grabber,in accordance with an implementation.

FIG. 23 is a perspective view of a portion of an endoscope, of adelivery catheter loaded into a working channel of the endoscope andthat includes a jaw grabber, and of a magnetic implant that includes aloop to enable the magnetic implant to be releasably attachable to adistal end of the delivery catheter using the jaw grabber, in accordancewith an implementation.

FIG. 24 is a perspective view of a portion of an endoscope, of adelivery catheter loaded into a working channel of the endoscope andthat includes a mechanically actuated jaw, and of a magnetic implantthat includes a ball to enable the magnetic implant to be releasablyattachable to a distal end of the delivery catheter using themechanically actuated jaw, in accordance with an implementation.

FIG. 25 is an exploded view of a magnetic implant having a compressionsurface that includes two standoff features, in accordance with animplementation.

FIG. 26 is a cross-sectional view of first and second magnetic implants,the first magnetic implant having a compression surface that includes astandoff feature configured to mate with a corresponding recess definedin a compression surface of the second magnetic implant, in accordancewith an implementation.

FIG. 27 is a side view of first and second magnetic implants andcorresponding retention members, with the first magnetic implant beingshown in contact with a vessel wall of a first hollow organ and thesecond magnetic implant being shown in contact with a vessel wall of asecond hollow organ, at the desired site of the anastomosis, inaccordance with another implementation.

FIG. 28 is a cross-sectional view of first and second magnetic implantsand corresponding retention members, the first magnetic implant having acompression surface that includes a standoff feature configured to matewith a corresponding recess defined in a compression surface of thesecond magnetic implant, in accordance with another implementation.

FIG. 29 is a cross-sectional view of first and second magnetic implantsand corresponding retention members, the first magnetic implant having acompression surface that includes two standoff features, in accordancewith another implementation.

FIG. 30A is a top view of first and second magnetic implants andcorresponding retention members, the first magnetic implant being shownin contact with a vessel wall of a first hollow organ, in accordancewith an implementation.

FIG. 30B is a side cross-sectional view of the first and second magneticimplant and corresponding retention members of FIG. 30A, the secondmagnetic implant being shown in contact with a vessel wall of a secondhollow organ.

FIG. 30C is a side view of the first and second magnetic implant andcorresponding retention members of FIG. 30A.

FIG. 30D is a front cross-sectional view of the first and secondmagnetic implant and corresponding retention members of FIG. 30A.

FIG. 31 is a top view of a magnetic implant and of a retention member,the retention member including multiple connection tabs provided in aspaced-apart relationship around an outer periphery of the magneticimplant, in accordance with an implementation.

DETAILED DESCRIPTION

Techniques described herein relate to systems, devices and methods forforming an anastomosis between two adjacent walls of hollow structuresof the digestive tract of a patient, in the context of procedures totreat various medical conditions associated with the digestive tract.The formation of the anastomosis can be achieved without puncturing thetissue of the hollow structures through which the anastomosis is formed,for example by inserting a first magnetic implant into the lumen of afirst hollow organ and a second magnetic implant into the lumen of asecond hollow organ, positioning the first and second magnetic implantsat a desired anastomosis site, and by magnetically coupling the firstand second magnetic implants together to compress the tissue of theadjacent walls therebetween. Compression of the wall tissue between thetwo magnetic implants results in a necrotic area that correspondsapproximately to the surface area of the compression surface of themagnetic implant pair. Over time, the necrotic area becomes surroundedby an edge of scar tissue, or scarred edge. The formation of scar tissuecan include collagen fiber deposition, neovascularization, andepithelial regeneration, and represents a dynamic equilibrium involvingcells, their milieu, and the extracellular matrix. Cytokines secreted byplatelets and inflammatory cells can promote the formation of new bloodvessels and collagen synthesis which, in dynamic balance with collagendegradation, can contribute to determine the healing response. Twocomponents of collagen are hydroxyproline and hydroxylysine, withhydroxyproline being synthesized under conditions of oxidative stressvia the hydroxylation of proline, and being involved in the cellulartransport of collagen. The synthesis and transport of wound collagen canthus be understood by monitoring the hydroxyproline content of thewound. The edge of scar tissue can thus be characterized by the fusion,or mechanical bonding, of the walls of each hollow organ through whichthe anastomosis is formed that occurs in part via fibrosis mechanisms.The scarred edge can thus form a fluid-tight seal around theanastomosis.

To facilitate maintaining the pair of magnetic implants in place for asufficient period of time to enable formation of the scarred edge andprevent premature passage of the pair of magnetic implants through thenecrotic area, a retention member can be associated with at least one ofthe magnetic implants, the retention member being configured to extendoutwardly from the corresponding magnetic implant. The retention membercan be any temporary or permanent structure that is coupled to themagnetic implant or that forms part of the magnetic implant, and isconfigured to prevent or inhibit the pair of magnetic implants fromprematurely passing through the necrotic area, i.e., prior to an edgehealing time period being completed, such that the magnetic implants andnecrotic tissue are released only after good scar formation is complete.For example, the retention member can include a flange or extension,provided continuously or discontinuously around the periphery of themagnetic implant. The retention member can also take several other formsand can include various features, for instance with regard to thematerials of which the retention member is made, geometriccharacteristics, configurations, and so on. One of the magneticimplants, or each of the magnetic implants, can be associated with acorresponding retention member such that the magnetically coupled pairof implants is prevented from passing through the necrotic region inboth directions.

Various implementations and features of the magnetic implant andassociated retention member will now be described in greater detail inthe following paragraphs.

General Description of the System for Forming an Anastomosis

With reference to FIGS. 1 to 6 , a system 10 for forming an anastomosisbetween two adjacent walls of hollow organs of the digestive tract isshown. Referring more particularly to FIG. 1 , in the implementationshown, the system 10 includes a first magnetic implant 12 forimplantation in the stomach, the first magnetic implant 12 beingidentified as a “stomach implant”; and a second magnetic implant 14 forimplantation in the jejunum, the second magnetic implant 14 beingidentified as a “jejunum implant”. It is to be understood that the term“implant” refers to a device that is implanted in the digestive tractfor a certain period of time, e.g., the healing time period, and that itcan be used interchangeably with the term “device” or “component” forinstance. In this implementation, the stomach represents a first holloworgan of the digestive tract into which the first magnetic implant 12can be implanted, and the jejunum represents a second hollow organ intowhich the second magnetic implant 14 can be implanted, so as to compressa portion of the stomach wall 13 and a portion of the jejunum wall 15therebetween.

In the Figures, each one of the first magnetic implant 12 and the secondmagnetic implant 14 is associated with a retention member 16, which isillustrated as corresponding to a flange 32 in FIG. 6 . In theimplementation shown, each one of the first magnetic implant 12 and thesecond magnetic implant 14 also includes a connecting member 18 that canbe releasably engageable with a connector 20, which in FIG. 1 isidentified as a delivery catheter. In other words, the magnetic implant12, 14 can include a feature that enables its connection to a connector20 for navigating the magnetic implant 12, 14 to a desired site forcreating the anastomosis. In turn, the connecting member 18 can includeany feature that enables a releasable connection of the magnetic implant12, 14 with the connector 20. In FIGS. 1-6 , the connecting member 18 isshown as a “catheter attachment” that includes a catheter attachmentassembly 46. The catheter attachment is configured as a receiving cavitythat can receive a distal end of the connector 20 therein, which asmentioned above can be a delivery catheter.

In some implementations and as shown in FIGS. 1-6 , the magnetic implant12, 14 can include a housing 22 that encloses a magnet 24 therein. Thehousing 22 can include for instance an outward portion 26 (or “outwardhousing” in FIG. 5 ) and an inward portion 28 (or “inward housing” inFIG. 5 ). The inward housing includes the portion of the housing thatfaces the corresponding other magnetic implant and is involved in themagnetic compression of the tissue, while the outward housing is on theopposed side of the magnetic implant facing away from the tissue beingcompressed. In this example, the two housing components surround themagnet and can be coupled together around a periphery thereof. Otherhousing constructions are also possible, where one or more housingcomponents are used to partly or fully enclose the magnet.

Each of these components of the system for forming an anastomosis willnow be described in further detail.

Description of the Magnetic Implant

Still referring to FIGS. 1-6 , the first magnetic implant 12 is a devicethat is implantable into a first hollow organ of the digestive tract ofa patient at a site of a desired anastomosis via the lumen of the firsthollow organ. Examples of hollow organs of the digestive tract includethe oesophagus, stomach, duodenum, jejunum, ileum, colon, biliary tract,and pancreatic duct. A site of desired anastomosis can be determinedaccording to the condition of the patient, and this aspect will not bediscussed further in the context of the present description. As usedherein, the expression “magnetic implant” refers to a structure that canbe implanted into the chosen hollow organ of the digestive tract, andthat can be magnetically attracted to another magnetic implant due tomagnetic forces. In some implementations, the magnetic implant canconsist of a magnet. In some implementations, the magnetic implant caninclude a magnet and one or more additional features, such as a housingand/or a connecting member. The two magnetic implants can besubstantially the same as each other, or different, in terms of theirshape, configuration, construction, and/or material make-up. Thesefeatures will be further discussed below.

The first magnetic implant 12 is used with a second magnetic implant 14to form am implant pair. The second magnetic implant 14 is a deviceimplantable into a second hollow organ of the digestive tract of thepatient to the site of the desired anastomosis via the lumen of thesecond hollow organ. The second hollow organ of the digestive tract islocated in sufficiently close proximity of the first hollow organ toenable the convergence of the respective wall tissue of the first holloworgan and the second hollow organ to eventually form the anastomosis.

The first and second magnetic implants 12, 14 are configured to remainwithin the digestive tract for at least a given healing time period. Thehealing time period enables necrosis of the anastomosis area whileproviding enough time for the edge of scar tissue to form. In someimplementations, after approximately 3 to 5 days following implantationof the pair of magnetic implants at the desired site of the anastomosis,the periphery of the anastomosis is strengthened by collagen deposition,with the formation an edge of scar tissue having an increased tensilestrength occurring at an estimated of approximately 7 to 10 daysfollowing implantation. The duration for forming the scar tissue canvary depending on the overall health of the individual patient, anddepending on the specific parts of the digestive tract being joined. Thescar tissue can also gain strength over the course of several additionalweeks. In some implementations, it may be desirable for the magneticimplants to be released and passed out of the body of the patient abouttwo weeks after implantation. In some implementations, the healing timeperiod can be about two weeks, or at least two weeks.

Each one of the first and second magnetic implants 12 can be navigatedto the site of the desired anastomosis using various techniques. Forinstance, the magnetic implants 12, 14 can be delivered to the site ofthe desired anastomosis endoscopically.

Each one of the first and second magnetic implants 12, 14 can have anysuitable shape and size determined in accordance with their intendedpurpose. In some implementations, the size and the shape of the magneticimplant can be determined for instance in accordance with thecharacteristics of the site of the desired anastomosis, the deliverytechnique chosen to deliver the magnetic implant to the site of thedesired anastomosis, and so on. In some implementations, the magneticimplant can have for example an elliptic shape, a circular shape, anelongated shape, a rectangular shape, an octagonal shape, or any otherpolygonal shape in terms of its cross-section. The magnetic implant caninclude rounded corners to facilitate navigation into the digestivetract. The magnetic implant can have an aspect ratio of about 1:1 (e.g.,in the case of a circular cross-section) or an aspect ratio of about 1:2to 1:40, about 1:3 to 1:20, about 1:4 to 1:15, for example, or anotheraspect ratio. In some implementations, the shape and size of theretention member 16 can be adapted in accordance with the shape and sizeof the corresponding magnetic implant. For instance, in someimplementations, the height of the magnetic implant can be proportionalto the thickness of the magnet contained therein and hence desiredmagnetic strength.

Each of the first and second magnetic implants 12, 14 includes acompression surface 30 that is configured to contact the tissue of thecorresponding hollow organ. The compression surface 30 can also bereferred to as a tissue-contacting surface, since it is the surface ofthe magnetic implant that is eventually in contact with the interiorwall of the hollow organ once the magnetic implant is delivered to thesite of the desired anastomosis. Each of the first and second magneticimplants 12, 14 also includes a lumen-oriented surface 42 opposite thetissue-contacting surface, the lumen-oriented surface generally facingthe lumen of the hollow organ once the magnetic implant is delivered tothe site of the desired anastomosis.

In some implementations, the compression surface 30 can be substantiallycontinuous and flat, as shown in FIGS. 1-6 . This can contribute toevenly distribute the force of the magnetic implant onto the tissue oncethe first and second magnetic implants 12, 14 are magnetically coupledtogether. In other implementations and with reference to FIG. 7 , thecompression surface 30 of the first magnetic implant 12 can have acomplementary shape compared to the compression surface 30 of the secondmagnetic implant 14. In the implementation shown in FIG. 7 , the firstmagnetic implant 12 has a curvilinear surface that is inwardly curved,i.e., concave, and the second magnetic implant 14 has a complimentarycurvilinear surface that is outwardly curved, i.e., convex, for thefirst magnetic implant 12 to mate therewith.

In other implementations, the compression surface 30 can includefeatures such as ridges, crests, furrows, grooves, and the like. Forinstance, the compression surface 30 of the first magnetic implant 12can include a series of ridges, and the second magnetic implant 14 caninclude a complimentary series of furrows such that when the first andsecond magnetic implants 12, 14 are magnetically coupled, the first andsecond magnetic implants 12, 14 can interlock and/or self-align toincrease the stability of their positioning on their respective sides ofthe first and second hollow organs. In some implementations, only one ofthe magnetic implants can include a compression surface having a convexfeature, as will be discussed in further detail below.

With reference to FIGS. 25 and 26 , in the embodiment shown, thecompression surface 30 of a first magnetic implant 12 includes twostandoff features 35 provided in a spaced-apart relationship. In theembodiment shown, the standoff features 35 are each represented as aconvex structure extending outwardly from the remainder of thecompression surface 30. In some implementations, the standoff feature 35can be configured to mate with a corresponding recess 37 defined in thecompression surface 30 of a second magnetic implant 14, such as shown inFIG. 26 . In some implementations and as mentioned above, complimentaryfeatures such as a combination of one or more standoffs andcorresponding recesses provided on respective compression surfaces 30 ofthe magnetic implants 12, 14 can contribute to provide a certain degreeof stability to the magnetic implants 12, 14 once implanted in thedigestive tract by limiting their range of motion in at least onedirection. In other implementations, the standoff feature 35 can beconfigured to abut a substantially plane surface of the compressionsurface 30 of a second magnetic implant 14, such as shown in FIG. 29 .

In some implementations, the size, and more particularly the height ofthe standoff feature 35 can be determined so as to limit the distancebetween the magnetic implants 12, 14 to set a maximum allowablecompression of the tissues. For instance, when the standoff feature 35has a height that is higher than the depth of the corresponding recess37, the top surface of the standoff feature 35 can abut the bottomsurface of the recess 37 such that a space 39 remains between theremainder of the respective compression surfaces of the magneticimplants, such as shown in FIG. 28 . In other implementations and asillustrated in FIG. 29 , when the compression surface 30 of a firstmagnetic implant 12 includes one or more standoff features 35 while thecompression surface 30 of a second magnetic implant 14 is substantiallyflat, the positioning of the compression surfaces against each other canalso result in a space 39 being defined between the remainder of therespective compression surfaces 30 of the magnetic implants 12, 14.

In some implementations, the standoff feature 35 can be of a size whichis smaller than the overall compression footprint, which can result in afocal pressure gradient around the standoff feature 35. The presence ofa focal pressure gradient can enable the tissue compressed by thestandoff feature 35 to necrose at a faster rate compared to thesurrounding magnetic compression area. In such implementations, a regionof “regular compression” can surround the standoff feature 35, which cancontribute to seal the region that is subjected to faster necrosisunderneath the standoff feature 35 from leaking.

In some implementations, the standoff feature 35 can contribute toincreasing the amount of shear force required to pull the magneticimplants 12, 14 apart or to slide the magnetic implants 12, 14 relativeto one another.

As mentioned above, the size and shape of the standoff feature 35 canvary. For instance, the standoff feature 35 can have any suitablegeometrical shape, e.g., circular, rectangular, or polygon-shaped. Thestandoff feature 35 can be provided with angled sides walls, such asshown in FIG. 28 , or with sides walls provided at a substantially rightangle, such as shown in FIG. 29 . The number of standoff features 35 canalso vary, and can range for instance from one to ten. More than tenstandoff features 35 can also be provided, in accordance with theintended application, and depending on the size of the compressionsurface 30. In some implementations, the number, shape and size of thestandoff features 35 can be determined in accordance with the size andshape of the surrounding magnetic compression area of the magneticimplant. For instance, in some implementations, a magnetic implanthaving a larger compression surface can include a higher number ofstandoffs features compared to a magnetic implant having a smallercompression surface.

In some implementations, the number, shape and size of the standofffeatures 35 can be determined so as to facilitate increasing shearstrength between the first and second magnetic implants 12, 14 toprevent disconnection of the first and second magnetic implants 12, 14.

In some implementations, the standoff feature 35 can be formed of abioresorbable material so that the magnetic force and pressure on thetissues may be limited for a given period of time, e.g., while the scartissue forms around the perimeter of the compression surface 30. Then,as the standoff feature 35 is subjected to bioresorption, the magneticstrength and hence pressure between the magnetic implants 12, 14 canincrease due to dissolution of the limiter, i.e., of the standofffeature 35.

In yet other implementations, the compression surface 30 can bediscontinuous and include void portions, i.e., where the wall tissue isnot contacted by a portion of the magnetic implant. For instance, withreference to FIG. 8 , the first and second magnetic implants 12, 14and/or the compression surfaces 30 thereof can have a donut shape, orannular shape. In some implementations, the first and second magneticimplants 12, 14 can have a similar size and a similar or complimentaryshape to facilitate the magnetic coupling through the wall tissues ofthe hollow organs. In other implementations, the first and secondmagnetic implants can 12, 14 can have a different size and shapedepending on the application and the sought-after characteristics of theresulting anastomosis.

In some implementations, the magnetic implant 12, 14 can include one ormore magnets. The magnet 24 can be any type of suitable magnet composedof the appropriate material. In some implementations, the magnet 24 canbe chosen according to its attractive force, i.e., according to thepressure that will be exerted on the surface area of the tissue thatwill eventually be compressed between the first and second magneticimplants 12, 14. Factors influencing the attractive force of the magnet24 can include the shape of the magnet 24, the thickness of the magnet24, the material of which the magnet 24 is made, etc. Example materialsinclude neodymium magnets (e.g., NdFeB magnets), rare earth magnets, andferrite magnets.

In some implementations, the magnet or magnets of a first magneticimplant may be made of a magnetic material that is not permanentlymagnetized, such as soft magnetic alloys, e.g., nickel-iron, siliconiron, iron, iron-cobalt, and ferritic stainless steels. In other words,the magnet(s) of respective magnetic implants may not be constructed oftwo permanent magnets. In other implementations, the magnets of a firstand second magnetic implants may be constructed of two permanentmagnets.

When the magnetic implant includes multiple magnets 24, the magnets 24can be connected to each other by a cable, a string, a ribbon, a hitch,or a combination thereof. For example, and with reference to FIGS.9A-9C, the magnetic implant can include multiple magnets provided inseries and in an adjacent relationship, the multiple magnets beingconnected together using a cable 76 that can be manipulated to yield anannular shape. Such a string of magnets can enable the magnetic implantto adopt a first configuration wherein the multiple magnets are providedsubstantially linearly to facilitate their navigation within the lumenof the hollow organ, and a second configuration wherein the multiplemagnets can take the form that the magnetic implant will have onceimplanted at the site of the desired anastomosis, which can by anygeometrical form. In the implementation shown in FIGS. 9A-9C, the formof the magnetic implant in the second configuration is an annular shape,but in other implementations, the multiple magnets can take other forms,and be for instance folded to obtain a polygonal shape without the voidspace, such as shown in FIGS. 10A-10D. With reference to FIGS. 11A-11D,the multiple magnets can also be provided in a first configurationwherein two layers of magnets are in a side-by-side relationship tofacilitate their navigation within the lumen of the hollow organ, andthen in a second configuration wherein the two layers of magnets becomespaced-apart, for instance due to the repulsive force of the magnets. Asmentioned above, the first configuration of the multiple magnets cangenerally be a configuration that facilitates their navigation withinthe lumen of the hollow organ, which can entail that the magneticimplant can adopt a configuration that enables it to fit within aworking channel of an endoscope, or alternatively that is connectable toa distal end of an endoscope, for instance via a delivery catheter. Themultiple magnets can thus be interconnected in any suitable manner thatsubsequently enables the formation of a geometrically-shaped array onceimplanted in the digestive tract, such as a linear array, a circulararray, or an octagonal array.

Although not explicitly shown in FIGS. 7-11 and 20-24 , it is to beunderstood that at least one or each of the magnetic implantsrepresented in FIGS. 7-11 and 20-24 can be associated with a retentionmember as described herein.

Housing

In some implementations, the magnetic implant 12, 14 can include ahousing 22 configured to house a magnet therein. An example of housing22 is shown in FIGS. 1-6 . More particularly in FIGS. 4 and 5 , thehousing 22 is shown as including an outward portion 26 and an inwardportion 28. In the context of the present description, the terms“outward” and “inward” when referring to the housing 22 are used inaccordance with a radial reference system, in which the wall of thehollow organ is considered to be outwardly positioned relative to thelumen of the hollow organ. When the housing 22 is present, the outwardportion 26 of the housing 22 is the portion that includes thelumen-oriented surface 42 of the magnetic implant, and the inwardportion 28 of the housing 22 is the portion that includes thetissue-contacting surface or the compression surface 30. In theimplementation shown, the outward portion 26 and the inward portion 28together fully enclose a single magnet 24 therein. In otherimplementations, the single magnet can be fully enclosed in asingle-piece housing, i.e., a housing 22 that is made of a single unit,the single unit including the tissue-contacting surface 30 and thelumen-oriented surface, 42 in accordance with the description above.

In some implementations, the magnetic implant can include a housing thatis configured to receive multiple magnets therein. Providing multiplemagnets within a single housing can contribute to enhancing theflexibility of the magnetic implant, such that it can become easier tobend when subjected to a force. Alternatively, the multiple magnets caneach be received in a corresponding housing, and the multiple magnetscan be connected to each other by a cable, a string, a ribbon, a hitch,or a combination thereof, as described above. In implementations whereeach magnet is received in a corresponding housing, the variousconfigurations described above in reference to FIGS. 9-11 are similarlyapplicable, although in this case multiple housings are present.

In the same order of ideas, the description made above regarding thecharacteristics of the compression surface 30 of the magnetic implant isapplicable to the housing 22 when the housing is present or whenhousings are present.

Description of the Retention Member

Referring back to FIGS. 1 to 6 , the system 10 for forming ananastomosis between two adjacent walls of hollow organs of the digestivetract further includes a retention member 16 that extends, or projects,outwardly from a corresponding one of the first and second magneticimplants 12, 14. Reference to an outward extension when describing theretention member 16 is also made in accordance with a radial referencesystem, with an outward extension meaning an extension or projectionaway from the compression surface 30 of the magnetic implant, e.g., awayfrom a center of the compression surface 30 of the magnetic implant.

The retention member 16 can be any structure that enables the retentionof the pair of magnetic implants 12, 14 in position once magneticallycoupled and during the healing time period, to prevent the first andsecond magnetic implants 12, 14 to prematurely pass through the necroticarea.

In some implementations, the retention member 16 can also be anystructure that enables providing additional buttress to the magneticimplant during the healing time period, and the retention member 16 maybe configured such that it applies a pressure that may be sufficient tocause necrosis but at a slower rate than the necrosis occurring betweenthe compression surfaces 30 of the magnetic implants 12, 14 once theyare magnetically coupled. The magnetic implants 12, 14 and the retentionmembers 16 can then eventually separate from the healed anastomosis andpass into the stool.

In other implementations, the retention member 16 can be configured toapply additional buttress to the anastomosis by engaging the peripheryof the anastomosis at a pressure interference amount that does notresult in necrosis of the tissue that is in contact with the retentionmember 16. In such implementations, the retention member “footprint” islarger than the desired anastomosis, and the interference resulting fromthe presence of the retention member 16 can prevent the magneticimplants 12, 14 from passing though the anastomosis even after thetissue has necrosed between the compression surfaces 30 of the magneticimplants 12, 14 and the tissue has separated from the anastomosis. Insuch implementations, the retention member 16 can be formed of abioresorbable material that is configured to resorb at a given timepointduring the healing time period and eventually disintegrates to the pointwhere the interference is no longer sufficient to maintain the pair ofmagnetic implants 12, 14 in place at the anastomosis site, and themagnetic implants 12, 14 are now small enough to pass through theanastomosis and be eliminated in the stool.

The retention member 16 can thus be configured to provide enough timefor the scar edge to form during the healing time period, and also toprovide additional buttress or strength to keep the magnetic implants12, 14 from decoupling or the tissue from perforating or tearing due toloads on the anastomosis site and connected bowel and stomach tissues.Examples of external or internal loads can include the weight of thebowel or stomach moving due to patient movement and/or internal loadsfrom peristalsis, bowel spasm/constriction, and internal gas pressurechanges.

In some implementations, the retention member 16 can be configured toprovide additional mechanical support to prevent premature separation ofthe magnetic implants 12, 14, tissue stretching/tearing or leak due tophysiologic loads that can result for instance from the weight of thebowel segments and the forces imparted by patient movement,spasm/constriction of the vessels, internal gas pressure changes, etc.,on the healing anastomosis site and connected vessels.

In some implementations, the retention member 16 can be configured is soas to not impart enough compression to cause necrosis but to provide anadditional surface area to distribute the physiologic loads duringhealing. As such, the retention member 16 can be configured to be inintimate contact with the outside surface of the vessel wall once thecompression surfaces 30 are magnetically coupled and has compressed thetissues.

In some implementations and with reference to FIGS. 1-6, and 12-15 , theretention member 16 can include a flange 32 that extends continuouslyaround substantially the entire periphery of the corresponding magneticimplant. The flange 32 may extend around the entire periphery or mayextend around all but a small portion of the periphery. In otherimplementations and with reference to FIGS. 16 and 17 , the retentionmember 16 can include a series of flange extensions that are provided ina spaced-apart relationship around the periphery of the correspondingmagnetic implant. When a series of flange extensions is provided as theretention member 16, the flange extensions are disposed as discreteflanges located at given locations, i.e., extending radially, around theperiphery of the corresponding magnetic implant and in a number suchthat the retention member 16 can retain the pair of magnetic implants12, 14 once implanted in the digestive tract of the patient andmagnetically coupled. An example of a series of flanges can include afirst flange and a second flange diametrically opposed to the firstflange. Another example of a series of flanges can include a firstflange at 12 o'clock, a second flange at 3 o'clock, a third flange at 6o'clock, and a fourth flange at 9 o'clock, such as shown in FIG. 16 .The location and number of the flanges of a series of flanges can bedetermined at least in part by the characteristics of the tissue againstwhich the magnetic implant will rest, the desired stability of themagnetic implant once implanted in the digestive tract, the material ofwhich is made the flanges, and the mechanism by which the flanges caneventually defeat, among others. The size of the flanges, when providedas a series of discrete flanges, can also vary according to variousfactors. In some implementations, the flanges can be thin flanges thatare smaller width compared to their length. In such implementations, theflanges can be referred to as discrete arms, or discrete fingers.

With reference to FIGS. 12 and 13 , the retention member 16 comprises anoutwardly-extending inner surface 34 oriented toward the tissue of thedigestive tract. The outwardly-extending inner surface 34 can include acurvature, as shown in FIG. 12 , or can be substantially flat, as shownin FIG. 13 . In some implementations, the length 36 of theoutwardly-extending inner surface 34 is chosen so as to retain thecorresponding magnetic implant in position during the healing timeperiod, once the magnetic implants 12, 14 are magnetically coupled toeach other. The length 36 of the outwardly-extending inner surface canbe for instance between about 0.5 mm and about 10 mm.

In addition, the retention members 16 of a pair of magnetic implants 12,14 can be configured to maintain a gap 38 between theoutwardly-extending inner surface 34 of a first magnetic implant 12 andthe outwardly-extending inner surface 34 of a second magnetic implant 14once implanted in the digestive tract. In some implementations, the gap38 can be such that a space remains between the outwardly-extendinginner surface 34 and the outer surface of the vessel, such as shown inFIG. 13 . In other implementations, the gap 38 can be such that theoutwardly-extending inner surface 34 contacts or gently presses theouter surface of the vessel, such as shown in FIG. 19 .

In some implementations, the gap 38 can be for instance at least 0.2 mmor at least 10.0 mm. In some implementations, the gap 38 can be between0.2 mm and 10 mm.

FIGS. 30A-30D illustrate another example of a pair of magnetic implants12, 14 being magnetically coupled to each other through the vessel wallof the stomach, shown in dark pink, and the vessel wall of the jejunum,shown in pale pink. In FIG. 30D, the gap 38 is shown as “G”, and theretention member 16 is shown as having a T-shaped configuration whenviewed as a cross-section. In FIGS. 30A-30D, the retention member 16 isprovided alongside the periphery of the housing 22 of each of themagnetic implants 12, 14.

Examples of approximate dimensions, in millimeters, that the magneticimplants can have in certain scenarios are provided in Table 1 below,with reference letters A to G being as illustrated in FIGS. 30A-30D.

TABLE 1 A B C D E F G Example #1 25.4 6.35 3.175 7.747 44.196 7.75 2.3Example #2 25.4 6.35 3.175 7.747 44.196 12.7 2.3 Example #3 25.4 6.353.175 7.747 44.196 16.5 2.3

In some implementations, the retention member 16 can be rigid and retainits configuration once the magnetic implants 12, 14 are magneticallycoupled to each other in the digestive tract, for instance when theoutwardly-extending inner surface 34 of the retention member 16 isconfigured not to contact the outer surface of the vessel.

In other implementations, in order to ensure that the pressure exertedon the tissue located underneath the outwardly-extending inner surface34 still permits blood to circulate in that area, the retention member16 can be flexible and/or connected to the magnetic implant in aflexible manner such that the retention member 16 can yield when the twomagnetic implants 12, 14 magnetically couple. This feature can enablethe combination of the magnetic implant and retention member 16 to adaptto different tissue thickness depending on the hollow organ into whichit is implanted. In implementations where the outwardly-extending innersurface 34 of the retention member 16 contacts the outer surface of thevessel, the retention member 16 can also be rigid, as long as thepressure exerted by the outwardly-extending inner surface 34 on the areaof the tissue does not result in necrosis of the tissue in that specificarea. In some implementations and with reference to FIG. 18 , theretention member 16 can include a thinner area 31 that can contribute toenhance the flexibility thereof.

The retention member 16 also includes an outwardly-extending outersurface 40 that can be continuous with a top surface 42, orlumen-oriented surface, of a corresponding magnetic implant, as shown inFIGS. 1-6, 12 and 13 . In other implementations, the transition from theoutwardly-extending outer surface 40 to the top surface 42 can include acurvature or a step change, for example.

The retention member 16 can be provided substantially parallellyrelative to the compression surface 30 of the magnetic implant, as shownin FIGS. 1-6, 12 and 13 . Alternatively, with reference to FIGS. 14 and15 , the retention member 16 can be provided at an angle relative to thecompression surface 30. The retention member 16, or flange 32, can beprovided at various locations along the height, or thickness, of themagnetic implant. For instance, in the embodiment shown in FIG. 27 , thetransition from the outwardly-extending outer surface 40 to the topsurface 42 includes a step change, such that the retention member 16 isprovided in a middle region in terms of the height of the magneticimplant, and the retention member 16 includes a downwardly-orientedcurvature, i.e., a curvature that is oriented toward the tissue once themagnetic implant is implanted at the site of the desired anastomosis. Insome implementations, a retention member comprising this type ofcurvature can contribute to avoid compressing the tissue beyond acertain degree of force. In addition, in some implementations and asillustrated in FIG. 27 , the retention member 32 of the first magneticimplant 12 can terminate above, or higher, the tissue-contactingsurface, or compression surface 30, of the corresponding first magneticimplant 12. The terms “above” or “higher” are used in reference to theouter surface of the organ wall against which the compression surface 30of the magnetic implant rests. Thus, in FIG. 27 , theoutwardly-extending inner surface 34 of the first magnetic implant 12 isoriented toward the tissue of the digestive tract and is located above,or higher, than the outer surface of the tissue of the first organ,while the outwardly-extending inner surface 34 of the second magneticimplant 14 can be said to be oriented toward the tissue of the digestivetract and is located below, or lower, than the outer surface of the wallof the first organ.

In some implementations, the retention member 16 can be sized andconfigured so as to prevent passage of the pair of magnetic implants 12,14 through the necrosis area during the healing time period due toincreased edema and spasm/constriction, but once healed, i.e., absenceof edema and spasm/constriction, etc., the size and configuration of theretention member 16, in combination with physiologic loading stretching,compliance, and flexibility of the vessel walls eventually enables themagnetically coupled pair of magnetic implants 12, 14 to pass and exitthe body of the patient. In some implementations, this scenario can beachieved without the use of bioresorbable materials being present in theretention member 16.

In some implementations, the retention member 16 can be configured suchthat once the magnetic implants are magnetically coupled, the retentionmembers 16 compress the tissues to the point of necrosis or at leastapply a gradient of pressure from an inwardmost portion of the retentionmember 16 extending to an outermost portion of the retention member 16,albeit to a lesser amount of pressure compared to the pressure exertedby the compression surfaces 30 of the magnetic implants, such that alonger period of time may be required for completing the healingcompared to the necrosis region defined between the compression surfaces30.

When the magnetic implant includes a housing 22, the retention member 16can be provided as an integral structure with the housing 22. Thisscenario can be envisioned for instance when the housing 22 and theretention member 30 are made of the same material, but can also beimplemented when the housing 22 and the retention member 30 are made ofthe different materials. In other implementations, the retention member30 can be provided as a discrete structure from the housing 22, and canbe attachable, couplable or otherwise engageable with the housing 22.

In some implementations, the retention member 16 is configured to bedefeatable once the healing time period is completed. In the context ofthe present description, the term “defeatable” refers to the capacity ofthe retention member 16 to modify its configuration or structure oncethe healing time period is completed, or at a given timepoint during orafter the healing time period. The retention member 16 can be defeatableaccording to various mechanisms of which examples are provided in thefollowing paragraphs.

The retention member 26 can be defeatable for instance mechanically orchemically via dissolution or degradation mechanisms.

When the retention member 16 is defeatable mechanically, it is meantthat the retention member 16 has a structure that can be manipulated(e.g., by a person), for instance using an endoscope or externally, todirectly or indirectly contact the retention member 16 to move theretention member 16 to a position or configuration that allows passageof the magnetic implants through the anastomosis.

For example, the retention member 16 can include one or more portionsthat promote the breaking apart of the retention member 16 from theremainder of the magnetic implant to facilitate the passing of thecoupled magnetic implants through the necrotic area, which isillustrated as necrotic area 44 in FIG. 12 . The breaking apart of theretention member 16 can be facilitated for instance due to the presenceof a different material, or due to a given configuration of theretention member 16.

Alternatively, the retention member 16 can include one or more weakenedportions, such as thinner portions 31 shown in FIG. 18 , or otherwisedisplaceable portions, that promote folding or displacement of theretention member 16 in a given direction such that the coupled magneticimplants can pass through the necrotic area.

In some implementations, the retention member 16 can be connected to thehousing 22 via multiple connection tabs 78, the multiple connection tabs78 contributing to increase the surface area thereof which in turn canfacilitate dissolution and breaking off of the connection tabs 78. FIG.31 illustrates a top view of an example of a retention member 16 thatincludes multiple connection tabs 78 provided in a spaced-apartrelationship around an outer periphery of a magnetic implant.

In some implementations, the retention member 16 can include adefeatable portion that is breakable into smaller pieces, which canlater on be passed naturally, so as to reduce the size of the retentionmember 16 so that it can also be passed naturally. The breaking apart orthe folding or displacement of the retention member 16 can be achievedby the dissolution, degradation, or fragmentation of the retentionmember 16 or a portion thereof. In order to do so, the retention member16 can be made of a material, or can be made of one or more portionsmade of a material that, when subjected to a particular set ofconditions, changes configuration or make-up. In the case of a retentionmember 16 that is defeatable, the change in configuration is one thatfacilitate the passing of the coupled magnetic implants through thenecrotic area. The set of conditions can include a duration, which cancorrespond to the healing time period, the pH surrounding the retentionmember 16, and the temperature surrounding the retention member 16. Forinstance, it can be determined that a material known to dissolve ordisintegrate after about two weeks, at a strong acidic pH and attemperatures of about 37° C. would be suitable to be used for theretention member 16 on a magnetic implant intended to be implanted inthe stomach.

In some implementations, the retention member 16 can include a portionthat is foldable against the magnetic implant for delivery within thedigestive tract, the foldable portion being configured to unfurl oncethe magnetic implant is implanted within the digestive tract.

In some implementations, the retention member 16 can be configured toadopt a retracted configuration for delivery within the digestive tract,and an expanded configuration once the magnetic implant is implanted inthe digestive tract.

The retention member 16 can include a biasing mechanism to enable thetransition from the retracted configuration to the expandedconfiguration. The retention member 16 can thus adopt a firstconfiguration, e.g., a folded or retracted configuration, thatfacilitates its for delivery to the site of the desired anastomosis, anda second configuration, e.g., unfolded or expanded, that enables theretention member 16 to fulfill its intended purpose of retaining thecoupled magnetic implants in position once delivered and implanted atthe site of the desired anastomosis. The first configuration can be onewhere the retention member 16 has smaller dimensions such that it can bemore easily navigated within the hollow organ of the digestive tract. Incontrast, the second configuration can be one where the retention memberis spread out and is capable of retaining the coupled magnetic implantsin position once implanted at the site of the desired anastomosis andduring the healing time period.

The retention member 16 can be configured such that the coupled magneticimplants are passed via manipulation of an external magnet or by anendoscopic device. In other implementations, the retention member 16 canbe configured such that the coupled magnetic implants are passednaturally at the end of the healing time period, i.e., without externalmanipulation.

In some implementations, the shape, size, and/or configuration of thefirst magnetic implant can be similar to the configuration of the secondmagnetic implant. In other implementations, the shape, size, and/orconfiguration of the first magnetic implant can be different from theconfiguration of the second magnetic implant. The choice of whether touse a pair of magnetic implants that include similar or differentmagnetic implants can depend for instance of the hollow organ into whichthe respective magnetic implants will be implanted. Whether or not themagnetic implants are similar, the retention member of the respectivemagnetic implant can also be similar or different, in terms of size,shape, and/or configuration. Once again, the respective hollow organsinto which the magnetic implants will eventually be implanted can be afactor in determining whether the corresponding retention member couldbe similar or different.

Materials

Details regarding different materials that the retention member 16 andthe housing 22, if present, can be made of will now be provided.

In some implementations, the retention member 16 can be made of orinclude a bioerodible material, biodegradable material, and/orbioresorbable material. A bioerodible material, such as a bioerodiblehydrogel, refers to a material, such as a polymer, that exhibits acontrolled degradation in a given environment such as underphysiological conditions, for instance by undergoing surface erosion. Abiodegradable material refers to a material that is susceptible tobreakdown, decomposition or degradation under the action of biologicalprocesses, such as by enzymatic action. A bioresorbable material refersto a material that can be resorbed or dissolved naturally underphysiological conditions. As mentioned above when describing thescenario where the retention member 16 can be defeatable, a retentionmember 16 that is made of or that includes one or more portions that aremade of a bioerodible material, a biodegradable material, or abioresorbable material provides the retention member 16 with an initialshape and initial dimensions that enable the retention member 16 toretain the coupled magnetic implants in position during the healing timeperiod while over time, the dimensions of the retention member 16 areeventually reduced sufficiently to pass through the necrotic area and beevacuated either naturally or with the support of an external means, forinstance via resorption of the retention member 16 itself, or followingbreaking into passable sized objects.

For instance, the retention member 16 can be made of an aliphaticpolyester or a combination of aliphatic polyesters, or can include oneor more portions made of an aliphatic polyester or a combination ofaliphatic polyesters. The aliphatic polyester can be a syntheticaliphatic polyester. Examples of aliphatic polyester include polylacticacid, polyglycolic acid, polylactic-co-glycolic acid, polycaprolactone,and polydioxanone.

The retention member 16 can be made of at least two materials, each ofthe materials having a different dissolution rate or a differentdegradation rate once implanted in a given environment, and in thiscase, in the respective hollow organ into which is implanted themagnetic implant. The difference in dissolution rate or degradation ratebetween the at least two materials can result in certain pre-determinedportions of the retention member 16 to weaken, which in turn can promotethe defeatability of the retention member 16. The pre-determinedportions of the retention member 16 can be for instance notches or thinspots provided at strategic locations. In some implementations, thedissolution and/or degradation occurring at these strategic locationscan be dependent on the pH of the environment where it is implanted. Forinstance, one or more pre-determined portions of the retention member 16can be subjected to an accelerated dissolution and/or degradation in astrongly acidic environment compared to a weakly acidic environment.Alternatively, one or more pre-determined portions of the retentionmember 16 can be subjected to an accelerated dissolution and/ordegradation in a basic environment compared to an acidic environment,for instance when the magnetic implant is intended to be in contact withpancreatic juice, bile and/or pancreatic enzymes. Other considerationsthat can influence the degradation of the one or more pre-determinedportions of the retention member 16 can include the presence of bacteriawith or without lytic enzymes, and possible drugs interactions such aswith H2-receptor blockers or proton pump inhibitors.

In some implementations, the retention member 16 of both the firstmagnetic implant 12 and the second magnetic implant 14 can be made ofthe same material. This scenario can be implemented for instance whenthe physiological environment of the corresponding two hollow organs ofthe digestive tract is similar. A similar physiological environment canrefer for example to the approximately neutral pH within two segments ofthe small intestine.

In other implementations, given the property of bioerodible materials,biodegradable materials, or bioresorbable materials to erode, dissolveor degrade at a given rate depending on the environment, a firstmaterial can be chosen for the retention member 16 of the first magneticimplant 12 for implantation in a given hollow organ, and a secondmaterial, different from the first material, can be chosen for theretention member 16 of the second magnetic implant 14 for implantationin a different given hollow organ. The retention member 16 of the firstmagnetic implant 12 and the retention member 16 of the second magneticimplant 14 can then dissolve or degrade based on the differences in thephysiological environment in the respective hollow organs over thehealing time period. For example, when the first magnetic implant 12 isintended to be implanted in the stomach, where the pH is stronglyacidic, and the second magnetic implant 14 is intended to be implantedin the jejunum, where the pH is weakly acidic, the material of theretention member 16 of the first magnetic implant 12 can be differentfrom the material of the retention member 16 of the second magneticimplant so as to obtain a similar dissolution rate or degradation ratebetween the two retention members 16. In other words, the design of eachretention member can be based on the properties of the hollow organ andcorresponding tissue wall (including the tissue thickness, tissuesurface characteristics, internal pH and conditions of the hollow organ,and/or other physiological properties) such that the two retentionmembers are defeated after approximately the same time interval.

In other implementations, the retention member 16 can comprise amaterial that is generally not susceptible to dissolution ordegradation, and that would be considered a durable material onceimplanted in the hollow organ. Examples of such materials can bepolymers such as silicones, e.g., polydimethylsiloxane; or afluoropolymer, e.g., polytetrafluoroethylene. Other examples can includea titanium alloy, cobalt chromium, or an austenitic stainless steel.Other examples can also include any other suitable biocompatiblematerial that retains its integrity for a duration longer than thehealing time period.

In some implementations, the magnetic implant on the distal side of theanastomosis, i.e., further away from the mouth of the patient, may beassociated with a larger retention member than the retention memberassociated with the magnetic implant located on the proximal side sincethe distal side of the magnetic implant does not have to pass throughthe anastomosis, i.e., for natural elimination, as it is already distalto the anastomosis. In some implementations, the retention member on thedistal side of the anastomosis can be non-resorbable.

The retention member 16 can also be made of a self-expandable materialor of a shape-memory material. An example of a shape-memory alloy isnitinol. Nitinol is a nickel-titanium shape-memory alloy, and has ashape that is temperature dependent. Other examples of shape-memorymaterials can include shape-memory polymers. The self-expandablematerial can enable the retention member 16 to adopt a constrainedconfiguration for delivery to the site of the desired anastomosis, andonce the constraint is removed, i.e., once the magnetic implant isdelivered to the site of the desired anastomosis, the retention member16 can adopt a deployed configuration that enables the retention member16 to retain the magnetic implant in position during the healing timeperiod. In implementations where the retention member 16 is made of atemperature-dependent shape-memory material, the retention member 16 canalso adopt a constrained configuration for delivery to the site of thedesired anastomosis, and once the magnetic implant is delivered to thesite of the desired anastomosis and thus following exposure tophysiological temperatures, the retention member 16 can resume itsoriginal shape, which can correspond to a deployed configuration thatenables the retention member 16 to retain the magnetic implant inposition during the healing time period.

Additional Considerations Regarding the Housing and the Retention Member

In implementations where the magnetic implant includes a housing 22,various scenarios are possible with regard to the respective materialsof which they can be made. The housing 22 and the retention member 16can be made of similar or same materials. This scenario can enable thehousing 22, or a portion thereof, and the retention member 16 to bemanufactured in a same manufacturing process, such that the housing 22and the retention member 16 are integral with each other, or indifferent manufacturing processes. Alternatively, the housing 22, or aportion thereof, and the retention member 16 can be made of differentmaterials. In this scenario, the housing 22 and the retention member 16can be manufactured in a same manufacturing process or in differentmanufacturing processes. When the housing 22 and the retention member 16are manufactured in different manufacturing processes, the retentionmember 16 is configured to be attachable, connectable, couplable, orengageable to/with the housing 22 following the different manufacturingprocess.

In some implementations, an additive manufacturing method can be used tomanufacture the housing 22 and/or the retention member 16. An additivemanufacturing method can refer to a method for manufacturing athree-dimensional object by adding layer over layer of given material(s)to obtain a plurality of layers according to a three-dimensional model,the plurality of successive layers being bonded together, for instanceby sintering or melting, to form the three-dimensional object. In someimplementations, the additive manufacturing method is a 3D printingmethod. The additive manufacturing method can facilitate the productionof objects having complex geometries, compared to conventionalsubtractive methods.

Additive manufacturing methods encompass a broad spectrum of methods,such as, but not limited to, binder jetting, directed energy deposition,material extrusion such as fused deposition modeling (FDM), materialjetting, powder bed fusion, sheet lamination, vat photopolymerization,combinations thereof, or any other method(s) as known in the art.

In some implementations, the housing 22 may be formed of one or multiplepieces. For instance, FIG. 5 shows a magnetic implant 10 that includes ahousing having a top and bottom portions with a parting line where theymate together once assembled, also referred to as the outward portion 26and the outward portion 28. The parting line may be incorporatedanywhere along the thickness of the magnetic implant. The clamshellconstruction allows for easy assembly and encapsulation of the componentparts that reside within the housing 22, such as the magnet, thedelivery system attachment mechanisms, etc. The housing 22 and itsinternal components may be bonded together using adhesives or thermallyreflowed or overmolded if the housing 22 is formed of a thermoplasticresin. If the housing 22 is made of a metallic material, the partingline of the top and bottom housing may be laser welded to bond thehousing together and create a hermetic seal around the magnetic core, ormagnet 24.

Housing and/or Retention Member Having Drug-Delivery Properties

In some implementations, the housing, if present, and/or the retentionmember can be configured to enable release of a given drug therefrom. Inorder to do so, the housing and/or the retention member can be made of amaterial that acts as a matrix that includes the given drug, or peptide,with the drug being progressively released as the material undergoesdegradation once subjected to certain environmental conditions. In suchimplementations, the housing and/or the retention member can be said toact as a controlled drug delivery system. Such controlled drug deliverysystem can advantageously deliver a given drug locally in the regionwhere the anastomosis is forming. The drug that may be chosen to bedelivered in the localized region of the anastomosis can be for instancea drug that have pro-thrombosis properties, or any type of wound-healingproperties. The housing and/or retention member can thus be designed tooffer an opportunity to deliver a drug than can influence the healingprocess of the anastomosis and formation of the scarred edge, with thehousing and/or the retention member thereby each playing an additionalrole in the formation of the anastomosis. Various materials can be usedto provide the controlled drug delivery system, which can also bereferred to as a delivery matrix. In some implementations, the deliverymatrix forming the housing and/or the retention member can include abioerodible material such as polylactic acid, polyglycolic acid, andpolylactic-co-glycolic acid. In other implementations, the deliverymatrix can include a durable material such as polydimethylsiloxane(silicone). Any other type of biocompatible material that enablesachieving a sustained drug release therefrom can be considered withinthe scope of the present description.

Examples of pro-thrombosis drugs, or antifibrinolytic drugs, includetranexamic acid, aprotinin, epsilon-aminocaproic acid,aminomethylbenzoic acid, and aminocaproic acid. Other examples of drugthat can be delivered and released locally at the anastomosis region caninclude insulin, matrikines, and antibiotics.

Examples of peptides having wound-healing properties that can beincluded within the housing and/or the retention member to be releasedtherefrom are listed in Table 2 and Table 3 below.

TABLE 2Examples of wound-healing peptides having antimicrobial propertiesPeptide Name Peptide Sequence AG30MLSLIFLHRLKSIVIRKRLDRKLRLWHRKNYP (SEQ ID NO: 1) AG30/5CMLKLIFLHRLKRMRKRLKRKLRLWHRKRYK (SEQ ID NO: 2) AH90ATAWDFGPHGLLPIRPIRIRPLCG (SEQ ID NO: 3) CW49 APFRMGICTTN (SEQ ID NO: 4)Cys-KR12 CKRIVKRIKKWLR (SEQ ID NO: 5) Esculentin-1a(1-21)GIFSKLAGKKIKNLLISGLKG (SEQ ID NO: 6) hBD-1DHYNCVSSGGQCLYSACPIFTKIQGTCYRGKAKCCK (SEQ ID NO: 7)(Disulfide bridges: 5-34, 12-27, 17-35) hBD-2GIGDPVTCLKSGAICHPVFCPRRYKQIGTCGLPGTKCCKKP (SEQ ID NO: 8)(Disulfide bridges: 8-37, 15-30, 20-38) hBD-3GIINTLQKYYCRVRGGRCAVLSCLPKEEQIGKCSTRGRKCCRRK K (SEQ ID NO: 9)(Disulfide bridges: 11-40, 18-33, 23-41) hBD-4ELDRICGYGTARCRKKCRSQEYRIGRCPNTYACCLRK (SEQ ID NO: 10)(Disulfide bridges: 6-33; 13-27; 17-34) Histatin-1DSHEKRHHGYRRKFHEKHHSHREFPFYGDYGSNYLYDN (SEQ ID NO: 11) Histatin-2RKFHEKHHSHREFPFYGDYGSNYLYDN (SEQ ID NO: 12) Histatin-3DSHAKRHHGYKRKFHEKHHSHRGYRSNYLYDN (SEQ ID NO: 13) IDR-1018VRLIVAVRIWRR (SEQ ID NO: 14) LL-37LLGDFFRKSKEKIGKEFKRIVQRIKDFLRNLVPRTES (SEQ ID NO: 15) MSI-78GIGKFLKKAKKFGKAFVKILKK (SEQ ID NO: 16) (pexiganan) Pep19-2.5GCKKYRRFRWKFKGKFWFWG (SEQ ID NO: 17) PLL-37PLLGDFFRKSKEKIGKEFKRIVQRIKDFLRNLVPRTES (SEQ ID NO: 18) SHAP1APKAMKLLKKLLKLQKKGI (SEQ ID NO: 19) SR-0007MLKLIFLHRLKRMRKRLKRK (SEQ ID NO: 20) SR-0379MLKLIFLHRLKRMRKRLKRK¹ (SEQ ID NO: 21) Temporin AFLPLIGRVLSGIL (SEQ ID NO: 22) Temporin B LLPIVGNLLKSLL (SEQ ID NO: 23)¹Lowercase letters indicate D-amino acid residues; Peptide highlightedin bold was entered into clinical trials for its assessment in thetreatment of diabetic foot ulcers; S: phosphoserine.

TABLE 3 Examples of wound-healing peptides Peptide Name Peptide SequenceAc-PGP N-acetylated-PGP BioGHK Biotinylated-GHK Col4-1MFRKPIPSTVKA (SEQ ID NO: 24) Comb1DINECEIGAPAGEETEVTVEGLEPG (SEQ ID NO: 25) E1GETGPAGPAGPIGPVGARGPAGPQGPRGDKGETGEQ (SEQ ID NO: 26) Tiger17WCKPKPKPRCH (SEQ ID NO: 27) TP-508AGYKPDEGKRGDACEGDSGGPFV (SEQ ID NO: 28) TSN1NFQGVQNRFVFGTP (SEQ ID NO: 29) TSN2 MENAELDVPIQSVFTR (SEQ ID NO: 30)TSN3 NTDNIYPESSC (SEQ ID NO: 31) TSN4 PYLGYVFK (SEQ ID NO: 32) TSN5MQTVAQLFKTVSSLSLST (SEQ ID NO: 33) TSN6HSPDIQLQKGLTFEPIQIK (SEQ ID NO: 34) TSN7STITQPYKTLNNARSP (SEQ ID NO: 35) TSN8 RPGPSPEGTGQSYNY (SEQ ID NO: 36)TSN9 MENAELDPPYLGYVFK (SEQ ID NO: 37) TSN10TGQSYNQYSQRPYLGVYVFK (SEQ ID NO: 38) TSN11 LYGQTPLETL (SEQ ID NO: 39)TSN12 ELADSPALEIG (SEQ ID NO: 40) TSN13LYGQTPLETLELADSPALEIG (SEQ ID NO: 41) TSN14VSGNTVEYALPTLE (SEQ ID NO: 42) TSN15 LDSPTAPTVQSTALTWRP (SEQ ID NO: 43)TSN16 LDGSAPGPLYTGSALDF (SEQ ID NO: 44) TSN17GSEGVRSGRSG (SEQ ID NO: 45) TSN18 QPQPLPSPGVGGKN (SEQ ID NO: 46)Tylotoin KCVRQNNKRVCK (SEQ ID NO: 47) UN1 ELLESYIDGR (SEQ ID NO: 48) UN2TATSEYQTFFNPR (SEQ ID NO: 49) UN3ELLESYIDGRPTATSEYQTFFNPR (SEQ ID NO: 50) WKYMVm WKYMVM¹ (SEQ ID NO: 51)¹Lowercase letters indicate D-amino acid residues; Peptide highlightedin bold was entered into clinical trials for its assessment in thetreatment of diabetic foot ulcers.

Additional examples of suitable peptides that can be part of thecontrolled drug delivery system include RADA-16, TDM-621, and TDM-623.RADA-16 is a synthetic amphiphilic peptide that can self-assemble intonanofibers and scaffolds in favor of cell growth, hemostasis and tissueengineering. TDM-621 and TDM-623 can act as hemostatic agents andtissue-sealing agents.

In some implementations, the delivery matrix can be configured toinclude more than one drug, and be designed to release the drugs in asequential manner to achieve a certain effect at a given time during thehealing time period. For example, the delivery matrix can includetranexamic acid, a wound-healing peptide, and an antibiotic. In such ascenario, the delivery matrix can be designed to release tranexamic acidfor instance within 24 hours of the implantation of the magneticimplants, and to release the wound-healing peptide after three or fourdays following the implantation of the magnetic implants. The deliverymatrix can further be designed to release the antibiotic at any timepoint during the healing period. When the delivery matrix is configuredto release more than one drug, the delivery matrix can be designed torelease selected drug substantially simultaneously. In someimplementations, when both the housing and the retention member are madeof a material that serves as a delivery matrix, the delivery matrixforming the housing can include a given drug that is the same as thegiven drug included in the delivery matrix forming the retention member.Alternatively, when both the housing and the retention member are madeof a material that serves as a delivery matrix, the delivery matrixforming the housing can include a drug that is different from the drugincluded in the delivery matrix forming the retention member.

In some implementations, bioerodible materials can also used in thecontext of interventions for creating an anastomosis with non-magneticcompressive implants, and other components that can be associated witheither magnetic compressive implants or non-magnetic compressionimplants such as sutures, and staples.

Housing and/or Retention Member Comprising One or MoreBiologically-Active Components

In some implementations, the housing and/or the retention member caninclude a material that is configured to encapsulate specific types ofcells that are intended to eventually be released out of the materialand thus in proximity of the anastomosis site, i.e., in the regionsurrounding the anastomosis site. In such implementations, the housingand/or the retention member can include a biologically active componentthat can contribute to facilitate the healing process, for instance bypromoting fibroblast activity, which in turn can shorten the time forforming the edge of scar tissue and contribute to forming an edge ofscar tissue having an increased tensile strength. For instance, in someimplementations, the housing and/or retention member can include amaterial configured to encapsulate fibroblasts, stem cells, or othertypes of cells, such as a bioresorbable material. The determination ofwhich cells to encapsulate can be made according to the desired effectthe cells may have once released from the material which, in the case ofthe formation of an anastomosis, can be related to wound healing. Insome implementations, the material can be a semi-permeable membrane thatencapsulates the cells, and also allows for diffusion of oxygen andnutrients into the membrane to provide viable conditions for the cells.

Delivery of the Pair of Magnets

Each one of the first and second magnetic implants 12, 14 can include aconnecting member connectable to a corresponding connector extendingfrom a corresponding endoscope to be releasably engageable with theconnector. The corresponding connector can be for instance a deliverycatheter 20. With reference to FIG. 5 , when the connector is a deliverycatheter, the connecting member can include a delivery catheterattachment assembly 46 connectable to the delivery catheter 20.

FIGS. 20-24 illustrate additional implementations of a connecting memberconnectable to a delivery catheter 20. Although not explicitly shown inthese Figures, it is to be understood that at least one of the magneticimplants represented in FIGS. 20-24 is associated with a retentionmember as described herein.

In some implementations, the connecting member can include a pommelsnare 52, also referred to as a knob feature, as shown in FIGS. 1-6, 20and 21 . In such implementations, the delivery catheter 20 can be loadedinto the working channel 48 of an endoscope 50, and the magnetic implant12 can be releasably attached to the distal end of the delivery catheter20 using a snare 54 that is wrapped around the pommel snare 52, or knobfeature, of the magnetic implant 12. The magnetic implant 12 can bedocked onto the delivery catheter 50 by applying tension to the snarewire 54 relative to the delivery catheter 20 and by locking the snarewire 54 relative to the delivery catheter 20 in a handle set that wouldbe positioned at the proximal end of the delivery catheter 20. As can beseen in FIGS. 20 and 21 , the pommel snare 52 can be located in a middleportion of the magnetic implant 12, or at a distal end thereof,respectively.

With reference to FIG. 22 , the connecting member can include a loop 56,and the connector can be a grabber 58 that includes a U-shaped jaw. Thegrabber 58 can be advanced distally relative to the delivery catheter 20so that the loop 56 can be able to leave the U-shaped jaw of the grabber58 once the magnetic implant 12 is delivered to the site of the desiredanastomosis.

With reference to FIG. 23 , the connecting member can be a loop 56, andthe connector can be a mechanically actuated jaw grabber 60. Themechanically actuated jaw grabber 60 can be used to grab the loop 56instead of the grabber 58 shown in FIG. 22 . The mechanically actuatedjaw grabber 60 includes a slot cut through it to accept the loop 56, andcan pull the loop 56 into the delivery catheter 20 while teeth 62 slideinto slot 64 provided on the magnetic implant 12.

With reference to FIG. 24 , the connecting member can be a ball 70, andthe connector can be a mechanically actuated jaw 66 that includes a slotfeature 68 configured to receive the ball 70 therein. In thisimplementation, the ball 70 can be part of the housing 22, which canfurther include a mating bar 72.

The implementations shown in FIGS. 1-6 and 20-24 are provided asexamples of various configurations that the connecting member and theconnector can take. Accordingly, it is to be understood that thedrawings and descriptions herein are proffered by way of example only,and that other types of connector and connecting member can also besuitable to enable the connection of the magnetic implant with adelivery device, such as an endoscope, so that the magnetic implant canbe delivered to the site of the desired anastomosis.

Method for Forming an Anastomosis in the Digestive Tract

A method for forming an anastomosis between two adjacent walls of adigestive tract of a patient will now be described in further detail.The method can include navigating a first magnetic implant into thedigestive tract of a patient to a first location, on one side of adesired anastomose site, within the lumen of a first hollow organ, andnavigating a second magnetic implant into the digestive tract of thepatient to a second location on another side of the desired anastomosesite, within the lumen of a second hollow organ.

Various techniques can be used to navigate, or deliver, the first andsecond magnetic implants to the desired site of the anastomosis. It isto be noted that a chosen technique for navigating or deliver the firstmagnetic implant can be the same or different compared to the chosentechnique for navigating or deliver the second magnetic implant. In someimplementation, the navigation of the magnetic implant can be performedvia a natural cavity of the patient, i.e., the mouth or the anus, usingfor example an endoscopic device.

In some implementations, navigating the first and second magneticimplants can include releasably engaging the first and second magneticimplants with a corresponding delivery catheter insertable in a workingchannel of a corresponding endoscope via a connecting member.

In some implementations, at least one of the first and second magneticimplants can be navigated to the site of the desired anastomosis using alaparoscopic procedure. Details regarding various types of suitablelaparoscopic procedures and laparoscopic instruments and devices can befound described in U.S. Patent Application No. 2020/0138438A1, which isincorporated herein by reference in its entirety.

Once the magnetic implants are delivered within their respective holloworgan and on their respective side the of the desired anastomosis, thefirst and second magnetic implants can be brought in close proximity toenable magnetic coupling of the first and second magnetic implantsthrough the two adjacent vessel walls of the digestive tract, such thatthe compression surface of each of the first and second magneticimplants contacts the interior wall of their respective hollow organ atthe site of the desired anastomosis. The magnetic coupling of the twomagnetic implants compresses a portion of the two adjacent wallstherebetween, and the portion that is compressed between the respectivecompression surfaces of the magnetic implants eventually forms anecrotic area as the blood flood supply to this area progressivelydeclines.

As at least one of the first and second magnetic implants is associatedwith a retention member extending outwardly therefrom, the first andsecond magnetic implants are retained in position on either side of thetwo adjacent walls during a healing time period to enable formation of ascarred edge surrounding the necrotic area. Retaining the first andsecond magnetic implants in position during the healing time periodprevents the coupled first and second magnetic implants to pass throughthe necrotic area prematurely, e.g., before the healing time period iscompleted.

In some implementations, the retention member can be defeatable once thehealing time period is completed, and the method can thus furtherinclude mechanically defeating the retention member using an endoscopefollowing the healing time period.

In some implementations, the first and second magnetic implants can bemanipulated by using a magnet externally, for instance to facilitate thepassing of the coupled magnetic implants via the bowel lumen of thepatient once the healing time period is completed. An endoscope can alsobe used to manipulate the coupled magnetic implants internally, also tofacilitate their passing via the bowel lumen of the patient once thehealing time period is completed.

Several alternative implementations and examples have been described andillustrated herein. The implementations of the technology describedabove are intended to be exemplary only. A person of ordinary skill inthe art would appreciate the features of the individual implementations,and the possible combinations and variations of the components. A personof ordinary skill in the art would further appreciate that any of theimplementations could be provided in any combination with the otherimplementations disclosed herein. It is understood that the technologymay be embodied in other specific forms without departing from thecentral characteristics thereof. The present implementations andexamples, therefore, are to be considered in all respects asillustrative and not restrictive, and the technology is not to belimited to the details given herein. Accordingly, while the specificimplementations have been illustrated and described, numerousmodifications come to mind.

The invention claimed is:
 1. A system for forming an anastomosis betweentwo adjacent walls of a digestive tract, the system comprising: firstand second elongated magnetic implants each comprising an outer sidewall and a compression surface extending inwardly from a compressionperimeter defined by the outer side wall, the first and second elongatedmagnetic implants being configured for placement within a correspondinghollow organ of the digestive tract and to magnetically couple to eachother through the two adjacent walls of the digestive tract to compressa portion of the two adjacent walls therebetween and form a necroticarea that becomes surrounded by a scarred edge following a healing timeperiod; and a retention member extending outwardly from the outer sidewall of at least one of the first and second elongated magnetic implantsto define a retention member perimeter that is larger than thecompression perimeter, the retention member comprising anoutwardly-extending inner surface that is spaced back from thecompression surface of the at least one of the first and secondelongated magnetic implants, the entirety of the retention member beingconfigured to remain within the corresponding hollow organ and retainthe first and second elongated magnetic implants in position and preventpassage thereof through the necrotic area during the healing timeperiod.
 2. The system of claim 1, wherein the at least one of the firstand second elongated magnetic implants comprises a housing configured tohouse a magnet therein.
 3. The system of claim 2, wherein the retentionmember comprises a flange or a series of flanges that is integral withthe housing.
 4. The system of claim 2, wherein the retention membercomprises a flange or a series of flanges that is discrete from thehousing.
 5. The system of claim 2, wherein the retention membercomprises a series of flanges extending around the outer side wall ofthe at least one of the first and second elongated magnetic implants,the flanges being provided in a spaced-apart relationship relative toone another.
 6. The system of claim 2, wherein the retention member andthe housing are made of a same material.
 7. The system of claim 2,wherein the retention member and the housing are made of a differentmaterial.
 8. The system of claim 1, wherein the retention membercomprises a flange or a series of flanges.
 9. The system of claim 8,wherein the flange extends continuously around substantially an entireperiphery of the outer side wall of the at least one of the first andsecond elongated magnetic implants.
 10. The system of claim 1, whereinthe retention member comprises a continuous rim extendingcircumferentially around the outer side wall of the at least one of thefirst and second elongated magnetic implants.
 11. The system of claim10, wherein the retention member has a T-shaped cross-section.
 12. Thesystem of claim 1, wherein the retention member comprises at least oneof a bioerodible material, a biodegradable material, and a bioresorbablematerial.
 13. The system of claim 1, wherein the retention membercomprises at least two materials, the at least two materials having adifferent dissolution rate or a different degradation rate onceimplanted in a given environment.
 14. The system of claim 1, wherein theretention member comprises at least one notch or spot having adissolution rate or a degradation rate that is different from aremainder thereof once implanted in a given environment.
 15. The systemof claim 1, wherein each one of the first and second elongated magneticimplants comprises a corresponding retention member extending outwardlytherefrom, the corresponding retention member of the first and secondelongated magnetic implants being made of a same material.
 16. Thesystem of claim 1, wherein each one of the first and second elongatedmagnetic implants comprises a corresponding retention member extendingoutwardly therefrom, the corresponding retention member of the firstmagnetic implant being made from a different material than thecorresponding retention member of the second magnetic implant.
 17. Thesystem of claim 16, wherein the first elongated magnetic implant isconfigured for implantation in a strongly acidic environment and thesecond elongated magnetic implant is configured for implantation in aweakly acidic environment, and once implanted in the strongly acidicenvironment and in the weak acidic environment respectively, the firstand second elongated retention member have a similar dissolution rate ordegradation rate.
 18. The system of claim 1, wherein theoutwardly-extending inner surface of the retention member issubstantially flat.
 19. The system of claim 1, wherein theoutwardly-extending inner surface of the retention member comprises acurvature.
 20. The system of claim 1, wherein each one of the first andsecond elongated magnetic implants comprises a corresponding retentionmember the corresponding retention members being provided such that agap is defined between the outwardly-extending inner surfaces of thecorresponding retention members of the first and second elongatedmagnetic implants once implanted in the digestive tract.
 21. The systemof claim 1, wherein the retention member comprises a portion that isfoldable against the at least one of the first and second elongatedmagnetic implants for delivery within the digestive tract, the foldableportion being configured to unfurl once the at least one of the firstand second elongated magnetic implants is implanted within the digestivetract.
 22. The system of claim 1, wherein the retention member isconfigured to adopt a retracted configuration for delivery within thedigestive tract, and an expanded configuration once the at least one ofthe first and second elongated magnetic implants is implanted within thedigestive tract.
 23. A system for forming an anastomosis between twoadjacent walls of a digestive tract, the system comprising: first andsecond elongated magnetic implants each comprising an outer side walland a tissue-contacting portion extending inwardly from a compressionperimeter defined by the outer side wall, the first and second elongatedmagnetic implants being configured to magnetically couple to each otherthrough the two adjacent walls of the digestive tract to compress aportion of the two adjacent walls therebetween and form a necrotic areathat becomes surrounded by a scarred edge following a healing timeperiod, the tissue-contacting portion of the first elongated magneticimplant comprising: a standoff feature being configured to maintain aspace between respective tissue-contacting portions of the first andsecond elongated magnetic implants when the standoff feature contactsthe tissue-contacting portion of the second elongated magnetic implant;a retention member extending outwardly from the outer wall of at leastone of the first and second elongated magnetic implants to define aretention member perimeter that is larger than the compressionperimeter, the retention member being configured to retain the first andsecond elongated magnetic implants in position and prevent passagethereof through the necrotic area during the healing time period. 24.The system of claim 23, wherein the standoff feature includes aplurality of standoff features provided in a spaced-apart relationship.25. The system of claim 23, wherein the tissue-contacting portion of thesecond elongated magnetic implant is substantially flat.
 26. The systemof claim 23, wherein the tissue-contacting portion of the secondelongated magnetic implant comprises a recess having a shape that iscomplimentary to the standoff feature, the standoff feature having ahigher height than a depth of the recess.
 27. The system of claim 23,wherein the standoff feature comprises angled sides walls.
 28. Thesystem of claim 23, wherein the standoff feature comprises sides wallsprovided at a substantially right angle.
 29. The system of claim 23,wherein the standoff feature is configured to provide a focal pressuregradient therearound.